Human Error Investigations, Root Cause Determination and CAPA Effectiveness

Why Should You Attend:

Human error is known to be the major cause for quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior can be manipulated reducing the likelihood of these occurrences.

To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course will offer practical approaches to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

Learning Objectives:

• Understand human error: factors and causes.
• Understand the importance: regulatory and business.
• Define the process to manage human error deviations.
• Identify root causes associated to human error deviations.
• Identify what I can do to support human reliability.

Areas Covered in the Webinar:

• Background on human error phenomena
• Importance of human error prevention/reduction
• Training and human error
• Facts about human error
• Human error as the root cause
• What is human error
• How is human error controlled?
• Common mistakes: Memory failures, overconfidence, we believe we are above average, visual detection, vigilance effectiveness
• Types of error
• Human error rates and measurement
• Trending and tracking
• Prediction
• CAPA effectiveness

Who Will Benefit:

• Training managers and coordinators
• Operations
• Manufacturing
• Plant engineering
• QA/QC staff
• Process excellence/improvement professionals
• Industrial/process engineers
• Compliance officers
• Regulatory/legislative affairs professionals
• General/corporate counsel
• Executive management

Ginette M Collazo
Organizational Psychologist, Ginette M Collazo Inc

Ginette Collazo, PH.D, is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others. She has also implemented human error reduction programs and technology in many small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.

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